The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients

October 6, 2020 updated by: Technical University of Munich

Due to its high prevalence and the substantial individual and socio-economic burden chronic pain is a huge challenge for patients, physicians and the society. Using neuroimaging structural and functional alterations have been described in the brain of patients suffering from chronic pain (Apkarian, Hashmi et al. 2011, Baliki and Apkarian 2015). However, reproducibility and functional significance of these changes are only incompletely understood. For example it remains unclear, if these changes covariate with clinical parameters and if they can be influenced or reversed by appropriate therapy. Some of the structural and functional brain changes in chronic pain patients have been shown to be reversible using magnetic resonance imaging after successful interventional pain treatment (Seminowicz, Wideman et al. 2011) or cognitive-behavioral therapy (Seminowicz, Shpaner et al. 2013, Shpaner, Kelly et al. 2014). Interdisciplinary multimodal pain therapy (IMPT) as a biopsychosocial treatment approach comprising physiotherapy and psychotherapy in structured programs has been shown to be effective in alleviating chronic pain of different entities including those where interventional therapy options are lacking or have been unsuccessful (Kaiser, Treede et al. 2017). The present study aims to investigate the influence of a structured IMPT approach provided in a day-clinic program of 20 treatment days on the functional brain network structure in chronic pain patients. To this end, a graph-theory based analysis (Bullmore and Sporns 2009) will be applied to electroencephalography (EEG) resting-state data from 30 chronic pain patients before and after IMPT and results will be correlated with behavioral and clinical data. In this observational study chronic pain patients that have been screened for participation in IMPT as part of routine medical care are invited to participate in a baseline visit prior to participation and a follow-up visit 6 months after completion of the program.

This will add to a better understanding of the complex functional brain alterations in chronic pain and might contribute to identify neuronal markers or even predictors for therapeutic responses in multimodal pain treatments. Moreover, the broad availability and easy applicability of EEG-measurements might enable a wide therapeutic application of potential findings in the near future.

Study Overview

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Department of Neurology, Center for Interdisciplinary Pain Medicine, Klinikum rechts der Isar, TUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All chronic pain patients eligible according to the inclusion and exclusion criteria (see eligibility criteria) participating in the IMPT-day-clinic programme of the Center for Interdisciplinary Pain Medicine at the Klinikum rechts der Isar of the Technische Universität München in the year 2018 are invited to voluntarily participate in the study.

Description

Inclusion Criteria:

  • Chronic pain (duration >6 months, not primary headache disease)
  • Willing and able to comply with physical (e.g. able to get up from the floor without help) and psychological (e.g. motivation for behavioural change) requirements of the IMPT-day-clinic setting as assessed by a physician, psychologist and physiotherapist on a screening visit as part of routine medical care prior to participation
  • Willing and able to sign informed consent for study participation

Exclusion Criteria:

  • Recent change in chronic pain condition (e.g. surgery or injury within the last 3 months)
  • Concomitant neurological or psychiatric disease apart from Depression (especially severe mental disorder or psychopathology)
  • Regular (daily) intake of benzodiazepines
  • Addiction problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline visual analogue scale (VAS) ratings of pain intensity at 6 months
Time Frame: Measured at baseline and at 6 months post treatment
Pain rating for average Pain intensity within the last 4 weeks on the VAS ranging from 0=no pain to 10=worst imaginable pain
Measured at baseline and at 6 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Pain related disability / Quality of life / Depression / Pain characteristics at 6 months
Time Frame: Measured at baseline and at 6 months post treatment
Metrics assessed using the German Pain Questionnaire (Nagel, Gerbershagen et al. 2002), short-form McGill Pain Questionnaire (Melzack 1987), Beck Depression Inventory II (Beck et al 1986), painDETECT Questionnaire (Freynhagen et al 2006)
Measured at baseline and at 6 months post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline functional cerebral connectivity as assessed by resting-state Electroencephalography (EEG) at 6 months
Time Frame: Measured at baseline and 6 months post treatment
64-Channel-EEG resting state measurements and Graph-theory based analysis of frequency bands (gamma, beta, alpha, theta, delta) on sensor and source level including degree centrality, clustering coefficient, global efficiency, small-worldness, modularity und global hub disruption index
Measured at baseline and 6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Markus Ploner, Professor, MD, Department of Neurology, Klinikum rechts der Isar, TUM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 9, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (ACTUAL)

August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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